Palbociclib + Chemotherapy for Childhood Leukemia and Lymphoma

Recruiting at 18 trial locations

Age: < 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Children's Oncology Group

Must not be taking: CYP3A4 drugs

Disqualifiers: Pregnancy, Infections, Genetic syndromes, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 32 days

12 Participants Needed

Trial Summary

What is the purpose of this trial?

AINV18P1 is a Phase 1 study where palbociclib will be administrated in combination with a standard re-induction platform in pediatric relapsed Acute Lymphoblastic Leukemia (ALL) and lymphoblastic lymphoma (LL). LL patients are included because the patient population is rare and these patients are most commonly treated with ALL regimens. The proposed palbociclib starting dose for this study will be 50 mg/m\^2/day for 21 days.

Research Team

Elizabeth Raetz, MD

Principal Investigator

Children's Oncology Group

Eligibility Criteria

This trial is for children with relapsed Acute Lymphoblastic Leukemia (ALL) or Lymphoblastic Lymphoma (LL). They should have a certain level of bone marrow blasts, measurable disease, and be in good enough health to participate. Patients must not have been treated with palbociclib before and should meet specific heart, kidney, and liver function requirements.

Inclusion Criteria

I am mostly able to care for myself, regardless of my age.

My leukemia has relapsed at least once for T-lineage and twice for B-lineage.

I have never taken palbociclib or similar medications.

Exclusion Criteria

You are currently taking part in another study that involves testing an experimental drug.

I am not taking medication that strongly affects certain liver enzymes.

I do not have any infections that are currently uncontrolled.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Palbociclib in combination with chemotherapy for one cycle, 32 days

32 days

Multiple visits for drug administration and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Long-term follow-up

Participants are monitored for adverse events and response to treatment

Up to 26 months

Treatment Details

Interventions

• Palbociclib

Trial Overview The study tests the drug palbociclib combined with standard chemotherapy in pediatric patients who've had ALL or LL return after treatment. Palbociclib will be given at a starting dose of 50 mg/m^2/day for 21 days alongside re-induction chemotherapy.

Participant Groups

Group I: Treatment (Palbociclib) Experimental Treatment 9 Interventions

Patients receive Palbociclib 50 mg/m\^2 (starting dose with maximum dose of 100 mg) PO (or via NG-tube) once daily on Days 1-21; Intrathecal cytarabine (IT ARAC) age-based dosing on Day 1, Doxorubicin 60 mg/m\^2 IV push or infusion over 1-15 min on Day 4; Prednisone or prednisolone 40 mg/m\^2 PO divided BID or TID on days 4-31; Vincristine 1.5 mg/m\^2 (maximum dose 2 mg) IV push or mini-bag per institutional policy on days 4, 11, 18, and 25; and Pegaspargase 2500 IU/m\^2 IV over 1-2 hours on Days 5, and 18. If CNS3 leukemia is present, patients receive Intrathecal Triple Therapy (ITT) age-based dosing on days 4, 11, 18, and 25. Patients known to be CNS3 at study entry may receive ITT on Day 1 rather than IT ARAC. If CNS1 and 2 leukemia present, patient receive Methotrexate (IT MTX) age-based dosing on Days 18 and 32. Treatment will be given for one cycle, 32 days, in the absence of disease progression or unacceptable toxicity.

Who Is Running the Clinical Trial?

Children's Oncology Group

Lead Sponsor

Trials

467

Recruited

241,000+